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Opioid Analgesic

Cebranopadol for Acute Pain (ALLEVIATE1 Trial)

Phase 3
Waitlist Available
Led By Harold S. Minkowitz, MD
Research Sponsored by Tris Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires
Scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours
Awards & highlights
Pivotal Trial

Summary

"This trial will test how well Cebranopadol works and how safe it is for treating acute pain after Abdominoplasty surgery."

Who is the study for?
This trial is for individuals experiencing acute pain following an abdominoplasty, commonly known as a tummy tuck. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.
What is being tested?
The study aims to test the effectiveness and safety of Cebranopadol in managing acute pain after abdominoplasty surgery. It will compare results from patients taking Cebranopadol against those given a placebo.
What are the potential side effects?
While the side effects of Cebranopadol in this context are not detailed, common ones may include nausea, dizziness, headache, or constipation based on its action as a pain reliever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can attend all scheduled visits and complete all study tasks.
Select...
I am scheduled for a full tummy tuck without liposuction or other surgeries, as outlined.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure
Secondary study objectives
Measure
Other Secondary Endpoint

Side effects data

From 2016 Phase 3 trial • 76 Patients • NCT02031432
25%
Asthenia
25%
Malignant neoplasm progression
22%
Decreased appetite
20%
Nausea
14%
Constipation
12%
Fatigue
12%
Oedema peripheral
12%
Pyrexia
11%
Somnolence
11%
Headache
11%
Arthralgia
11%
Vomiting
11%
Back pain
9%
Dyspnoea
9%
Thrombocytosis
9%
Musculoskeletal pain
8%
Anaemia
8%
Leukopenia
8%
Thrombocytopenia
8%
Urinary tract infection
7%
Dizziness
7%
Leukocytosis
7%
Abdominal pain upper
7%
Bacteriuria
7%
Insomnia
5%
Gamma-glutamyltransferase increased
5%
Nervousness
5%
Abdominal pain
5%
Feeling drunk
5%
Depressed mood
5%
Anxiety
5%
Pain in extremity
5%
Upper respiratory tract infection
5%
Diarrhoea
3%
Concussion
3%
Anaemia of malignant disease
3%
Metastases to liver
3%
Haemoptysis
1%
Adjustment disorder with depressed mood
1%
Pneumonia
1%
Subarachnoid haemorrhage
1%
Erysipelas
1%
Cerebral infarction
1%
Coma
1%
Epilespsy
1%
Malignant melanoma
1%
Hydronephrosis
1%
Epididymitis
1%
Cardiac failure
1%
Superior vena cava syndrome
1%
Tumour haemorrhage
1%
Pain
1%
Alcohol abuse
1%
Confusional state
1%
Depression
1%
Facial bone fracture
1%
Subdural haemorrhage
1%
Colitis
1%
Ileus paralytic
1%
Acute kidney injury
1%
Skin lesion
1%
Osteonecrosis of jaw
1%
Dehydration
1%
Lung abscess
1%
Myocardial infarction
1%
Gastroenteritis
1%
Aortic thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cebranopadol

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment BExperimental Treatment1 Intervention
Cebranopadol 200 ug (once daily)
Group II: Treatment AExperimental Treatment1 Intervention
Cebranopadol 400/400 ug (once daily)
Group III: Treatment CPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cebranopadol
2013
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Tris Pharma, Inc.Lead Sponsor
21 Previous Clinical Trials
4,513 Total Patients Enrolled
1 Trials studying Acute Pain
240 Patients Enrolled for Acute Pain
Harold S. Minkowitz, MDPrincipal InvestigatorHD Research
~112 spots leftby Apr 2025
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